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Generated: June 20, 2019

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CLINICAL TRIALS PROFILE FOR LONSURF

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Clinical Trials for Lonsurf

Trial ID Title Status Sponsor Phase Summary
NCT01896856 Phase I Study of SGI-110 With Irinotecan Followed by Randomized Phase II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Previously Treated Metastatic Colorectal Cancer Recruiting Sidney Kimmel Comprehensive Cancer Center Phase 1/Phase 2 This is a phase I/randomized phase II study of the combination of SGI-110 and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or TAS-102.
NCT02602327 Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases Recruiting University of California, San Francisco Phase 1 This is a phase I dose escalation study (3+3 design) with a dose expansion arm (12 patients) designed to evaluate safety of the combination of Tas-102 and radioembolization using Yttrium-90 (90Y) resin microspheres for patients with chemotherapy-refractory liver-dominant chemotherapy-refractory metastatic colorectal cancer (mCRC).
NCT02654639 Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer Recruiting Georgetown University Phase 2 Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
NCT02920476 TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma Not yet recruiting Taiho Oncology, Inc. Phase 2 This is a non-randomized, open label, sequentially enrolling phase II study with a Simon two-step enrollment design to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of unresectable or metastatic recurrent squamous non-small cell lung cancers.
NCT02920476 TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma Not yet recruiting University of Florida Phase 2 This is a non-randomized, open label, sequentially enrolling phase II study with a Simon two-step enrollment design to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of unresectable or metastatic recurrent squamous non-small cell lung cancers.
NCT02921737 TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy Not yet recruiting Taiho Oncology, Inc. Phase 2 This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to evaluate the activity of TAS-102 in previously treated metastatic and locally advanced unresectable pancreatic cancer after progression through or intolerance to first line chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint is to determine the progression free survival (PFS) in subjects with unresectable pancreatic adenocarcinoma.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lonsurf

Condition Name

Condition Name for Lonsurf
Intervention Trials
Colorectal Cancer 3
Stage IVB Rectal Cancer AJCC v7 2
Metastatic Colorectal Cancer 2
Stage IV Rectal Cancer AJCC v7 2
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Condition MeSH

Condition MeSH for Lonsurf
Intervention Trials
Colorectal Neoplasms 10
Colonic Neoplasms 3
Rectal Neoplasms 3
Adenocarcinoma 3
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Clinical Trial Locations for Lonsurf

Trials by Country

Trials by Country for Lonsurf
Location Trials
United States 15
Germany 1
Czechia 1
Belgium 1
Netherlands 1
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Trials by US State

Trials by US State for Lonsurf
Location Trials
Florida 3
California 3
Minnesota 2
Texas 1
Kansas 1
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Clinical Trial Progress for Lonsurf

Clinical Trial Phase

Clinical Trial Phase for Lonsurf
Clinical Trial Phase Trials
Phase 3 1
Phase 2/Phase 3 1
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Lonsurf
Clinical Trial Phase Trials
Not yet recruiting 11
Recruiting 8
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Clinical Trial Sponsors for Lonsurf

Sponsor Name

Sponsor Name for Lonsurf
Sponsor Trials
Taiho Oncology, Inc. 4
National Cancer Institute (NCI) 3
University of Florida 2
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Sponsor Type

Sponsor Type for Lonsurf
Sponsor Trials
Other 15
Industry 10
NIH 3
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